• Genzyme (Cambridge, Massachusetts) reported commercial availability of cystic fibrosis (CF) gene sequencing, a new diagnostic that it said can detect about 98% of the more than 1,200 disease-causing mutations in the CFTR gene. Mutations in the CFTR gene can cause CF, as well as other health issues such as pancreatitis and male infertility. Mara Aspinall, president of Genzyme Genetics, a provider of testing services and the business unit of Genzyme, said the new test “will help physicians identify a greater number of patients [who] are impacted by CFTR-related diseases, and who otherwise may not have been diagnosed.” Most genetic CF testing is performed by mutation panels, which detect the most common CFTR mutations. CF gene sequencing detects the most common mutations, as well as less common mutations not included in the available mutation panels. According to the Cystic Fibrosis Foundation (Bethesda, Maryland), more than 10 million Americans are carriers of CF gene mutations.

• Repligen (Waltham, Massachusetts) reported the initiation of a clinical study to evaluate the diagnostic utility of RG1068, synthetic human secretin, in functional MRI (fMRI) of the pancreas. The study is designed to confirm and quantify the clinical observation that patients with pancreatic disease have reduced pancreatic fluid production in response to stimulation by secretin, which may be useful in early diagnosis of chronic pancreatitis. This is an investigator-initiated study conducted by the Indiana University School of Medicine in a total of 45 healthy volunteers and patients with chronic pancreatitis. The company said its device has shown efficacy in treating age-related macular degeneration (AMD) and glaucoma.

• Toshiba America Medical Systems (TAMS; Tustin, California) said it received FDA clearance for a new CAN Level 1 injector synchronization option for its Aquilion64- and 32-slice computed tomography (CT) systems. The new option facilitates contrast-enhanced CT exams by interfacing the CT scanner to a contrast injection system, giving clinicians the option to activate the contrast and the scanner without leaving the patient’s side. The new injector protocol will be available on all Aquilion CT systems equipped with Toshiba’s Version 3.0 software and is field upgradeable. Version 3.0 software supports synchronization of theinjector and CT system using the Level 1 scan protocoloption.

• Uroplasty (Minneapolis) said that it received FDA pre-market approval (PMA) for its Macroplastique Implants to market Macroplastique in the U.S. for the treatment of female stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency. Following market introduction, the company said it will conduct FDA-required post-approval studies to obtain market feedback on safety and effectiveness of the product. Uroplasty resident/CEO, David Kaysen, said, “We have been selling Macroplastique in Europe since 1991 and this approval allows us to commercialize the product in the United States. We expect to begin marketing this product in the United States in early 2007.” Macroplastique will be the company’s third product on the market in the U.S. Macroplastique Implants is one of what is known as “bulking agents” for SUI in females. The increased bulk from the agent is designed to allow the urethra to close more effectively, preventing urine from leaking during so-called “stress” activities.

• Zimmer (Warsaw, Indiana) said that the first cases using the Trinica Anterior Lumbar Plate (ALP) System have been completed in St. Louis. The Trinica ALP System is the first anterior lumbar plate system to accommodate vertebral body variation through multiple plate configurations with both fixed- and variable-angle screws for an enhanced bone-plate interface. Zimmer Spine expects to complete its full release of the Trinica ALP System in the U.S., Europe and Australia by the end of 2006. It was introduced at the recent North American Spine Society (NASS) conference in Seattle and was highlighted at the Congress of Neurological Surgeons (CNS) conference in Chicago.

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